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FDA 510(k) Application Details - K170873
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K170873
Device Name
Material, Tooth Shade, Resin
Applicant
SwissMediTec GmbH
Gfellen 26
Finsterwald 6162 CH
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Contact
Kurosh Sohi
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/23/2017
Decision Date
10/02/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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